Barbed-suture Efficiency Study for Sacrocolpopexy (BEST)
Status
Conditions
Treatments
Details and patient eligibility
About
Minimally invasive sacrocolpopexy (SCP) performed laparoscopically or with robotic assistance is associated with improved patient-centered outcomes such as faster recovery times, less pain, less bleeding, and shorter hospital stay, however at the expense of longer operating times. One of the time consuming parts of the procedure is vaginal mesh attachment.
Full description
The purpose of this research study is to compare two different suture types that are used to attach vaginal mesh that is typically used in women undergoing robotic or laparoscopic sacrocolpopexy (attachment of the vagina to the sacral promontory). The barbed suture is one continuous suture, while the delayed absorbable suture involves placing individual sutures and tying a knot for each. All women will have permanent sutures that attach the mesh to the sacral promontory, which is standard of care. The goal is to determine if the barbed delayed absorbable suture decreases the time of vaginal mesh attachment.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Age ≥21
- Subject must have apical with anterior or posterior vaginal prolapse with leading edge of prolapse to or beyond the hymen
- Subject reports a bothersome bulge they can see or feel per Pelvic Floor Disability Index (PFDI-20), question 3, response of 2 or higher
- Eligible for laparoscopic or robotic sacrocolpopexy
- Desires surgical treatment for symptomatic uterovaginal or vaginal vault prolapse
- English speaking
Exclusion criteria
- Patients who are not surgical candidates due to medical comorbidities
- Current foreign body complications (including but not limited to erosion, fistula, abscess). This covers foreign bodies of any type (e.g. synthetic and biologic including allograft, xenograft).
- Inability to give informed consent or to complete the testing or data collection.
- Anticipated circumstances resulting in an inability to follow up (geographic relocation, etc.).
- Active systemic infection including any gynecologic infection, untreated Urinary Tract Infection (UTI) or tissue necrosis.
- History of pelvic organ cancer (e.g. uterine, ovarian, bladder, or cervical).
- Prior or currently undergoing radiation, laser therapy, or chemotherapy in the pelvic area.
- Subject has taken systemic steroids (within the last month, steroid inhalers OK), or immunosuppressive or immunomodulatory treatment (within the last 3 months)
- Systemic connective tissue disease (e.g. scleroderma, Marfan's syndrome, Ehlers Danhlos, collagenosis, polymyositis or polymyalgia rheumatic, lupus)
- Chronic systemic pain that includes the pelvic area or chronic focal pain that involves the pelvis
- Poorly controlled diabetes mellitus (DM), as indicated by Hemoglobin A1c > 9
- Those requiring concomitant rectopexy
- Subject is not able to conform to steep Trendelenburg position
- Known sensitivity to polypropylene
- History of prior prolapse repair utilizing vaginal or abdominal mesh
- Planned vaginal mesh attachment placed transvaginally
- History of diverticulitis
Trial design
Primary purpose
Allocation
Interventional model
Masking
52 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Sachin Vyas, PhD
Data sourced from clinicaltrials.gov
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